Bristol Myers Squibb announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.
In the trial, treatment with Opdivo following neoadjuvant chemoradiation therapy (CRT) and complete surgical resection demonstrated a statistically significant improvement in the primary endpoint of DFS compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies. This is the second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting.
“Approximately 50% of patients with esophageal or gastroesophageal junction cancer who undergo neoadjuvant chemoradiation therapy followed by tumor resection will have disease recurrence within four years, and among those who do not respond completely to neoadjuvant treatment, recurrence will occur sooner,” said Ronan J. Kelly M.D., MBA, Director of the Charles A. Sammons Cancer Center at Baylor University Medical Center. “Medical oncologists have had limited to no treatment options to offer esophageal cancer patients who undergo neoadjuvant chemoradiation therapy followed by surgery and fail to demonstrate a complete pathological response. For the first time, we have a potential therapeutic option with nivolumab in the adjuvant setting for these patients.”
“Opdivo is the first and only therapy to improve disease-free survival, along with a manageable safety profile, for patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery,” said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “The results from CheckMate -577 are immensely important for physicians and patients, and have the potential to establish Opdivo as a new standard of care. We plan to provide our data to health authorities worldwide with the goal of bringing Opdivo as an adjuvant therapy to these patients with high unmet need.”
The company will complete a full evaluation of the available CheckMate -577 data and work with investigators to share the results at an upcoming medical conference, as well as discuss them with health authorities. The CheckMate -577 trial will continue as planned to allow for future analysis of the secondary endpoint of overall survival (OS).
Source: Company Press Release